HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-
treated sterile solution of purified gamma globulin containing anti-HBs. It
is prepared from plasma donated by healthy, screened donors with high titers
of anti-HBs that is purified by an anion- exchange column chromatography manufacturing
method9,10. HepaGam B (hepatitis b immune globulin human) is formulated as a 5% (50 mg/mL) protein solution
with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 mL
and 5 mL single dose vials. The product appears as a clear to opalescent liquid.
It contains no preservatives and is intended for single use. HepaGam B (hepatitis b immune globulin human) may be
administered intravenously or intramuscularly dependent upon indication [see
INDICATIONS]. The source plasma used in the
manufacture of this product was tested by FDA licensed Nucleic Acid testing
(NAT) for HIV-1 and HCV and found to be negative. An investigational NAT for HBV was performed on all Source Plasma used, and found to be negative; however,
the significance of a negative result has not been established. Plasma also
has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus
B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool
is set not to exceed 104 IU of B19 DNA per mL.

Hepatitis B Immune Globulin (Human) — HyperHEP B™ S/D treated
with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune
globulin for intramuscular administration; it is preservative-free and latex-free.
HyperHEP B S/D is prepared by cold ethanol fractionation from the
plasma of donors with high titers of antibody to the hepatitis B surface antigen
(anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II.
The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl
phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP)
and detergent (sodium cholate), the solution is heated to 30°C and maintained
at that temperature for not less than 6 hours. After the viral inactivation
step, the reactants are removed by precipitation, filtration and finally ultrafiltration
and diafiltration. HyperHEP B S/D is formulated as a 15–18% protein
solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperHEP B S/D
is then incubated in the final container for 21–28 days at 20–27°C. Each vial
contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs
in a U.S. reference hepatitisB immune globulin (Center for Biologics Evaluation
and Research, FDA). The U.S. reference has been tested against the World Health
Organization standard Hepatitis B Immune Globulin and found to be equal to 220international
units (IU) per mL.

CARMOL® HC is intended for topical administration. The active component
is the corticosteroid hydrocortisone acetate, which has the chemical name pregn-4-ene-3,
20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11?)-. It has the following
chemical structure.

Humulin is synthesized in a special non-disease-producing laboratory strain
of Escherichia coli bacteria that has been genetically altered to produce
human insulin. Humulin N (insulin human recombinant) [Human insulin (rDNA origin) isophane suspension] is
a crystalline suspension of human insulin with protamine and zinc providing
an intermediate-acting insulin with a slower onset of action and a longer duration
of activity (up to 24 hours) than that of Regular human insulin. The time course
of action of any insulin may vary considerably in different individuals or at
different times in the same individual. As with all insulin preparations, the
duration of action of Humulin N (insulin human recombinant) is dependent on dose, site of injection, blood
supply, temperature, and physical activity. Humulin N (insulin human recombinant) is a sterile suspension
and is for subcutaneous injection only. It should not be used intravenously
or intramuscularly. The concentration of Humulin N (insulin human recombinant) is 100 units/mL (U-100).

PANHEMATIN (hemin for injection) is an enzyme inhibitor derived from processed
red blood cells. Hemin for injection was known previously as hematin. The term
hematin has been used to describe the chemical reaction product of hemin and
sodium carbonate solution. Hemin is an iron containing metalloporphyrin. Chemically
hemin is represented as chloro [7,12-diethenyl-3,8,13,17-tetramethyl-21H,23H-porphine-2,18-dipropanoato
(2-)-N21,N22,N23,N24] iron. The
structural formula for hemin is: